Ischemic StrokeCARDIOSTROKENCT03710902
Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
A study testing ECG monitoring for 3 weeks and Self-monitoring of BP and self-titration of antihypertensive medication in people with Ischemic Stroke and Transient Ischemic Attack, run by Jukka Putaala at 4 sites in Finland.
Trial summary
The CARDIOSTROKE is a randomized trial comparing mobile-device assisted control of hypertension together with screening of occult atrial fibrillation to standard care in patients with recent ischemic stroke or transient ischemic attack. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack, Atrial Fibrillation
- What is being tested?
- ECG monitoring for 3 weeks and Self-monitoring of BP and self-titration of antihypertensive medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 4 sitesFinland
- Study dates
- 17 Oct 2018to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke or transient ischemic attack (ABCD2 score ≥3)
- Age ≥40 years
- Pre-existing or newly diagnosed hypertension
- Informed consent from the patient or legal representative
Who cannot join
- Known high-risk source of cardioembolism
- Known indication for anticoagulation
- Contraindication for anticoagulation
- Pacemaker
- Non-compliance to study interventions as judged by the investigator
- Serious condition hampering the study conduct
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anu Eräkanto contact
Finland4 sites, 4 recruiting
- Recruiting
Kanta-Häme Central Hospital
Hämeenlinna
Tiina Alapirtti, MD, PhD, tiina.alapirtti@khshp.fi
Elina Laakso, MD, elina.laakso@khshp.fi
- Recruiting
Helsinki University Hospital
Helsinki, 00290
Terhi Saarikoski, RN, +35894711, terhi.saarikoski@hus.fi
Tuomo Nieminen, Prof.
- Recruiting
Hyvinkää Hospital
Hyvinkää
Terttu Heinkinheimo-Connell, MD, PhD, terttu.heikinheimo-connell@hus.fi
Katariina Hirvonen, MD, katariina.hirvonen@hus.fi
- Recruiting
Päijät-Häme Central Hospital
Lahti
Tuomo Nieminen, MD, PhD, Prof., tuomo.nieminen@gmail.com
Anne Kerola, MD, PhD, anne.m.kerola@phhyky.fi
About this study
The CARDIOSTROKE is a randomized trial comparing mobile-device assisted control of hypertension together with screening of occult atrial fibrillation to standard care in patients with recent ischemic stroke or transient ischemic attack.
Read the detailed description
Atrial fibrillation (AF) and hypertension are among the main treatable risk factors for ischemic stroke and transient ischemic attack (TIA). Detecting paroxysmal atrial fibrillation in stroke patients is challenging, but highly relevant since anticoagulation can effectively reduce the risk of recurrent strokes. Furthermore, hypertension remains poorly controlled even after stroke despite multiple available treatment options. In the CARDIOSTROKE trial, the investigators aim to randomize 405 patients with recent ischemic stroke or TIA into (1) standard diagnostic work-up, follow-up and treatment (control group) and (2) 3-week ECG monitoring to detect occult AF and self-monitoring of blood pressure with mobile-device-assisted self-titration of antihypertensive medication (intervention group). Randomization will occur 2:1 into control and intervention groups. The co-primary outcomes include (1) incidence of new-onset AF and (2) difference in the mean blood pressure at 12-months.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack, Atrial Fibrillation, Hypertension, Empowerment
- Being tested
- ECG monitoring for 3 weeks, Self-monitoring of BP and self-titration of antihypertensive medication
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Atrial Fibrillation, Hypertension, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG monitoring for 3 weeksDiagnostic test
A 3-week continuous ECG monitoring to detect occult AF.
Self-monitoring of BP and self-titration of antihypertensive medicationOther
One-week monthly self-monitoring of BP and self-titration of antihypertensive medication according to a pre-specified protocol, assisted with a mobile device application.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Diagnostic Test: ECG monitoring for 3 weeks; Other: Self-monitoring of BP and self-titration of antihypertensive medication |
| Control | No intervention | Standard diagnostic work-up, follow-up, and treatment of hypertension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with New Atrial fibrillation
New diagnosis of atrial fibrillation (>30 s)
Measured: 12 months
Change in Blood Pressure
Mean change in systolic/diastolic blood pressure
Measured: 12 months
Secondary outcomes (3)
Number of Participants with New Cardiovascular Events within 12 Months
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Measured: 12 months
Number of Participants with New Cardiovascular Events within 36 Months
Any of stroke, myocardial infarction, revascularization, or cardiovascular death
Measured: 36 months
Health Care Costs
Total direct healthcare costs
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start17 Oct 2018
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jukka Putaala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jukka Putaala, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710902
- Sponsor's protocol ID
- HUS/53/2017
- Other IDs
- TYH2016127
- Acronym
- CARDIOSTROKE
- Status last verified
- Mar 2025
- First submitted
- 16 Oct 2018
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lumikari T, Putaala J, Pirinen J, Kerola A, Sibolt G, Granroth-Wilding H, Pakarinen S, Lehto M, Nieminen T. Empowerment and mobile technology in the detection and treatment of main cardiovascular risk factors of patients with ischemic stroke or transient ischemic attack: a protocol for a multicenter randomized controlled trial (CARDIOSTROKE). Trials. 2025 Mar 14;26(1):89. doi: 10.1186/s13063-025-08778-x.
PubMed 40082922
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03710902
- Acronym / sponsor ID
- CARDIOSTROKE / HUS/53/2017
- Conditions
- Ischemic Stroke, Transient Ischemic Attack, Atrial Fibrillation, Hypertension, Empowerment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Jukka PutaalaUniversity, hospital or other
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CARDIOSTROKE is a randomized trial comparing mobile-device assisted control of hypertension together with screening of occult atrial fibrillation to standard care in patients with recent ischemic stroke or transient ischemic attack.
Detailed description
Atrial fibrillation (AF) and hypertension are among the main treatable risk factors for ischemic stroke and transient ischemic attack (TIA). Detecting paroxysmal atrial fibrillation in stroke patients is challenging, but highly relevant since anticoagulation can effectively reduce the risk of recurrent strokes. Furthermore, hypertension remains poorly controlled even after stroke despite multiple available treatment options. In the CARDIOSTROKE trial, the investigators aim to randomize 405 patients with recent ischemic stroke or TIA into (1) standard diagnostic work-up, follow-up and treatment (control group) and (2) 3-week ECG monitoring to detect occult AF and self-monitoring of blood pressure with mobile-device-assisted self-titration of antihypertensive medication (intervention group). Randomization will occur 2:1 into control and intervention groups. The co-primary outcomes include (1) incidence of new-onset AF and (2) difference in the mean blood pressure at 12-months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: ECG monitoring for 3 weeks, Other: Self-monitoring of BP and self-titration of antihypertensive medication |
| Control | No intervention | –Standard diagnostic work-up, follow-up, and treatment of hypertension. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic stroke or transient ischemic attack (ABCD2 score ≥3)
- Age ≥40 years
- Pre-existing or newly diagnosed hypertension
- Informed consent from the patient or legal representative
Key exclusion criteria (6 listed)
- Known high-risk source of cardioembolism
- Known indication for anticoagulation
- Contraindication for anticoagulation
- Pacemaker
- Non-compliance to study interventions as judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG monitoring for 3 weeksA 3-week continuous ECG monitoring to detect occult AF. | Diagnostic test | Intervention |
| Self-monitoring of BP and self-titration of antihypertensive medicationOne-week monthly self-monitoring of BP and self-titration of antihypertensive medication according to a pre-specified protocol, assisted with a mobile device application. | Other | Intervention |
Primary outcome
Number of Participants with New Atrial fibrillation
Time frame: 12 months
New diagnosis of atrial fibrillation (>30 s)
Change in Blood Pressure
Time frame: 12 months
Mean change in systolic/diastolic blood pressure
3 secondary outcomes
Number of Participants with New Cardiovascular Events within 12 Months
Time frame: 12 months
Number of Participants with New Cardiovascular Events within 36 Months
Time frame: 36 months
Health Care Costs
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 40082922Lumikari T, Putaala J, Pirinen J, Kerola A, Sibolt G, Granroth-Wilding H, Pakarinen S, Lehto M, Nieminen T. Empowerment and mobile technology in the detection and treatment of main cardiovascular risk factors of patients with ischemic stroke or transient ischemic attack: a protocol for a multicenter randomized controlled trial (CARDIOSTROKE). Trials. 2025 Mar 14;26(1):89. doi: 10.1186/s13063-025-08778-x.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anu Eräkanto contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG monitoring for 3 weeks and Self-monitoring of BP and self-titration of antihypertensive medication in people with Ischemic Stroke and Transient Ischemic Attack, run by Jukka Putaala at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuomas Lumikari, MD (+35894711, tuomas.lumikari@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with New Atrial fibrillation (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03710902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.